Lead Scientist, Analytical Development

6 days ago

Watertown, Massachusetts, United States Alkermes Full time
About the Role

We are seeking a highly skilled and experienced Senior Analytical Development Scientist to join our team at Alkermes. As a key member of our Analytical Development team, you will provide technical leadership and expertise in small molecule analytical methodologies, driving the development of new drugs and ensuring their successful commercialization.

Key Responsibilities
  • Technical Leadership: Provide subject matter expertise in analytical development methodologies, guiding the development of analytical methods, and ensuring their implementation and validation.
  • Method Development and Validation: Design, execute, and analyze analytical method validation and transfer activities, ensuring compliance with ICH and FDA guidelines.
  • Collaboration and Communication: Work closely with colleagues across Pharmaceutical Development and Research organizations to leverage internal and external capabilities, equipment, and instrumentation to drive method performance.
  • External Partnerships: Provide technical support and management oversight of analytical activities at external partners, including product characterization, GMP in-process, release, and stability testing.
  • Regulatory Submissions: Develop, review, and approve analytical source documents, and author and review drug product and drug substance analytical sections for regulatory submissions.
  • Technical Presentations: Present technical data to cross-functional teams and senior management, effectively communicating critical analytical issues and solutions.
Requirements
  • Education: PhD (>8 years) or MS (>15 years) with related experience in analytical chemistry, organic chemistry, or biochemistry.
  • Expertise: Expertise and demonstrated experience in small molecule analytical method development, validation, and transfer.
  • Leadership: Demonstrated collaborative leadership, strong interpersonal skills, and excellent verbal and written communication skills.
  • Regulatory Knowledge: Expert understanding of ICH, FDA, and USP guidelines and the ability to apply these guidelines in the context of the stage of drug development.
  • Methodologies: Subject matter proficiency across a range of spectroscopic, titration, dissolution, and separation-based analytical methodologies and laboratory software systems.
About Alkermes

Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. As a fully-integrated, global biopharmaceutical company, we are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients.

We strive to foster a culture of diversity, inclusion, and belonging throughout our business, recognizing that our diversity of thought, background, and perspective makes us stronger. We are proud to have been recognized as an employer of choice by many national organizations, including being certified as a Great Place to Work in the U.S. in 2024, honored as a Healthiest Employer in both Ohio and Massachusetts in 2023, a Best Place for Working Parents in 2023, and to have received the Bell Seal at the Platinum level for Workplace Mental Health by Mental Health America for three consecutive years.

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